Director Medical Device Manufacturing Operations
About The Position
Castle Biosciences is growing and looking to hire a full-time Director Medical Device Manufacturing Operations to work from their Phoenix, AZ office location. This role will lead the startup and commercial launch of Castle's new manufacturing facility, from equipment installation and process validation through first production runs. The Director will build and lead the manufacturing team, including hiring managers, supervisors, and technicians, and establish the training and operational systems they need to succeed. This role will also own day-to-day manufacturing performance including safety, quality, delivery, and cost, while driving continuous improvement and ensuring ongoing FDA/ISO compliance within an FDA-regulated environment.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Operations Management, or related field
- 10+ years of progressive manufacturing leadership experience in medical device, diagnostics, or biotechnology industries
- At least 5 years in director-level or equivalent roles
- Proven experience leading manufacturing startup operations, greenfield site launches, or significant facility expansions in FDA-regulated environments (21 CFR 820, ISO 13485, GMP)
- Strong understanding of process validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation systems
- Must be legally authorized to work in the United States. Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.
Nice To Haves
- Advanced degree (MBA, MS Engineering, or related) preferred
Responsibilities
- Lead the startup and commercial launch of Castle's new manufacturing facility; from equipment installation and process validation through first production runs
- Build and lead the manufacturing team, including hiring managers, supervisors, and technicians
- Establish the training and operational systems they need to succeed
- Own day-to-day manufacturing performance including safety, quality, delivery, and cost
- Drive continuous improvement
- Ensure ongoing FDA/ISO compliance
Benefits
- Excellent Annual Salary + 35% Bonus Potential
- 20 Accrued PTO Days Annually
- 10 Paid Holidays
- 401K with 100% Company Match up to 6%
- 3 Health Care Plan Options
- Company HSA Contribution
- Company Stock Grant Upon Hire
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What This Job Offers
Job Type
Full-time
Career Level
Director
